Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 11:13 PM
Ignite Modification Date: 2025-12-25 @ 8:49 PM
NCT ID: NCT01625169
Description: There were no significant toxicities or adverse events attributable to Etravirine administration in any of the subjects who received study drug. Safety labs were obtained at D14 visit. No lab toxicities were observed.
Frequency Threshold: 0
Time Frame: Adverse Event reporting was collecting during the study and up through the last study visit.
Study: NCT01625169
Study Brief: Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HIV + Pregnant Women Etravirine PK on days 5 and 14 Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14. None None 0 9 6 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Breast Tenderness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View